Clinical Data Interchange Standards Consortium (CDISC, http://www.cdisc.org) is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
The CDISC SDTM (Study Data Tabulation Model) was designed to improve communications between sponsor organizations and regulatory authorities.
Industry-wide acceptance of the model has been increasing as industry and regulatory authorities face the challenges of analyzing pooled data from multiple studies.
Versante has developed a proprietary tool that is used to efficiently transform existing and legacy SAS datasets into CDISC SDTM compliant formats and standards. Our solution offers a rapid, low cost and error-free alternative.
 
 
Statistical Analysis and Reporting
Biometrics
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
 
 
 
 
 
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